Given 2004.
Methods | RCT – with an intervention group (IG) and control group (CG) | |
Participants | Patients diagnosed with a solid tumour and within 56 days of undergoing a first cycle of chemotherapy Country: USA Age: unclear Sex: Almost 80% of the total sample female Inclusion criteria:
Exclusion criteria
N randomised: n = 237; IG: n = 118; CG: n = 119 N in analysis: baseline: n = 237, IG: n = 118, CG: n = 199; 10 weeks: n = 191, IG: n = 97, CG: n = 94; 20 weeks: n = 167, IG: n = 80, CG: n = 87 |
|
Interventions |
Content of screen:HRQoL: Assessment of severity of problems and extent to which each of these problems impacted QoL ‐ dimensions. Problems assessed: alopecia, anxiety, constipation, depression, diarrhoea, nausea, dyspnoea, fatigue, fever, anorexia, insomnia, mucositis, pain, skin problems, lack of concentration, and physical and work role functioning; QoL dimensions assessed: emotions, relationships with others, sleep, appetite, daily activity, and concentration Interventionist: A nurse to conduct the screening/assessment and broader intervention Intervention procedure:SI with co‐intervention to use screening results: A 10‐contact, 20‐week intervention with symptom assessment. The computer documentation system provided up to 4 intervention strategies for each detected problem selected from the categories: information, counselling and support, co‐ordination of care, and prescribing therapeutic activities. Nurse discussed and entered participants’ choice into computer‐guided protocol. At all subsequent contacts, participants rated the severity and impact on symptoms for each specific intervention. Evaluation of each problem classified as: resolved, improving, no change, or deteriorating. Each of the in‐person sessions took approximately 1 hour Conditions for implementation
Comparative condition: Usual care group Length of follow‐up: 20 weeks |
|
Outcomes |
Primary outcomes: Depression (CES‐D) Secondary outcomes: / Outcome time points: baseline; 10 and 20 weeks |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation not specified |
Allocation concealment (selection bias) | Unclear risk | Unclear which method was used to conceal the allocation to conditions |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants, partners, and nurses not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information on blinding of telephone (outcome) interviewers |
Incomplete outcome data (attrition bias) All outcomes | High risk | Dropout from baseline to 20 weeks' postbaseline: 32% in control group, 27% in intervention group |
Selective reporting (reporting bias) | High risk | Data on participant characteristics are very limited, no clear presentation on the concrete depression data (CES‐D scores) or severity of problems data, only a lot of visuals and text on the assessed interactions. There is also no referral to a supplementary file for the concrete data |
Other bias | Unclear risk | Not clear whether the differently composed models are post hoc analyses or were planned in advance |